FDA Approval Requirements Changing?

There has been recent discussion around modifying FDA requirements for substantial support of both safety and efficacy in marketing applications. GZP examines the potential fallout on FDA review of drugs, biologics, vaccines, and combination products.

The issues as we see them, revolve around several major aspects of such changes:

Congressional approval of one of more laws that would modify or void the 1962 amendments to the Food. Drug. And Cosmetic Act and the Public Health Service Act

Effects on FDA morale and the potential for en masse resignations of that Agency’s Reviewers

Major pushback from physicians, who receive guidance on patient treatment from labels that contain summaries of evidence of both safety and effectiveness

Uncertainty in many patient communities with regard to selection of therapies

Resistance by insurers, who direct reimbursement

Competitive confusion and major effects on the marketplace worldwide, along with the investment community

In upcoming blogs we will examine each of the above topics of concern.

Stay tuned!

Written by Dr. Evan Siegel

Dr. Siegel founded Ground Zero Pharmaceuticals, Inc. (GZP) in 1999 from his consulting firm, Ground Zero Strategics, Ltd. He currently serves as its President and CEO, and is also the Chairman of the Board.